Human Research and Ethics Dr Michèle de Courcy Chair, Faculty of Education HEAG University of Melbourne

What’s ‘ethics’ about? Integrity of researchers, which involves: Commitment to –Contributing to knowledge –Pursuit & protection of truth –Reliance on appropriate research methods –Honesty

Basic ethical principles Respect for persons Beneficence Justice

Which projects need approval? Current University and NHMRC policy states that all research projects involving human participants as subjects are to be reviewed by institutional ethics committees.

Is it “research”? Does it involve… Interviews and focus groups Surveys and questionnaires Archived data which identifies individuals Observation Photography, audio/video taping Experimental procedures

Is it “research involving humans”? Is the research about –Establishing facts, principles or knowledge? –Obtaining or confirming knowledge? Does a person’s involvement have the potential to infringe one of the 3 basic principles?

What do ethics committees look out for? Is there a risk of physical, psychological, spiritual or emotional harm? Is there potential for infringement of privacy, confidentiality, or ownership? Does the person’s involvement impose burdens with little benefit?

Why do I need ethics approval? To protect the rights and welfare of human participants; To ensure that any risk of discomfort or harm to participants is minimal, and justified by the potential benefits of the research; To protect the University’s reputation for research conducted and sponsored by it;

Why? Continued … To minimise the potential for claims of negligence made against researchers and the University; To meet the University’s obligations under the NHMRC’s National Statement on Ethical Conduct in Research Involving Humans (June 1999)

The University of Melbourne - Ethics Structure One central Human Research Ethics Committee (HREC) – policy Three Human Ethics Sub-Committees (HESC) – review projects »Health Sciences HESC »Behavioural & Social Sciences HESC »Humanities & Applied Sciences HESC

Committee Composition of the HESCs Chair Layman and laywoman not associated with institution Member with knowledge/current experience in research considered by HREC Member knowledge/ current experience in professional care, counselling Lawyer Minister of religion Other co-opted members as required

Ethics Approval Process Application forms on Web - students to consult supervisors Submit to Faculty Human Ethics Advisory Group (FHEAG) for review and recommendation to HESC Some low risk projects can be approved by FHEAG, all must be reported to HESC Review or noting by HESC at monthly meeting Ethics office advises researchers re amendments or approval

What is my supervisor’s role? As a signatory of your application, your supervisor is responsible for: Briefing you about the requirements of the HESC when you are planning your project Guiding you in the completion of the application form Guiding you in the ethical conduct of your research

Ethics Approval Process No work to commence until written approval received Any amendments require approval Any incidents or adverse effects to be reported to ethics committee Annual report to be submitted for yearly renewal of approval Approval granted for up to 5 years

Issues for Ethics Committees Aim of research Methodology: good methodology = good ethics –Does what you say on the form match what you tell participants you are going to ask them to do? (in the PLS) Experience and training of researchers

Issues for Ethics Committees Participants »who are they? »vulnerability (more care) Risks vs. Benefits Risk Management »immediate and later »unexpected outcomes

Issues for Ethics Committees Recruitment: how? by whom? Dependent relationships: pupil/teacher; student/lecturer; family members; doctor/patient Cross cultural research: cultural sensitivities, translating, interpreting Confidentiality »legal limits »other limits e.g. small sample size »data storage

Issues for Ethics Committees Plain language statement & consent form »tailor to suit participants Informed consent: »clear full information »voluntary choice to participate Consent from whom: »parental consent for minors »legal guardians »community/organisations, as well as individuals?

Issues for Ethics Committees Publication of results of research Funding for research Conflict of interest? Payment to participants: compensation vs. inducement

External Documents American Psychological Association ethical principles of psychologists and code of conduct Children and Young Persons Act 1989 (in relation to Mandated Reporting Requirements) Australian Association for Research in Education (AARE) Code of Ethics NHMRC statement on Human research ethics Research in Government Schools Research in Catholic Schools

Internal sites and documents Faculty of Education Human Ethics site University of Melbourne Human Ethics site University of Melbourne Human Ethics “hints” page

Indigenous Research Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (NHMRC, June 1991) under review Guidelines for Ethical Research in Indigenous Studies (Australian Institute of Aboriginal and Torres Strait Islander Studies, 2000)